Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IGS VAGINAL SPECULUM

K-Number: K060129 · 2006-05-04

ApplicantInnovative Gynecological Solutions, LLC
Decision Date2006-05-04
Product CodeHIB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

IGS VAGINAL SPECULUM is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Gynecological Solutions, LLC. It received FDA 510(k) clearance on 2006-05-04 under 510(k) number K060129. The device is classified under product code HIB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IGS VAGINAL SPECULUM?

IGS VAGINAL SPECULUM is a medical device that received FDA 510(k) clearance on 2006-05-04. The listed applicant is Innovative Gynecological Solutions, LLC. The 510(k) number is K060129.

When did IGS VAGINAL SPECULUM receive FDA 510(k) clearance?

IGS VAGINAL SPECULUM received FDA 510(k) clearance on 2006-05-04, under 510(k) number K060129.

Who is the listed applicant for IGS VAGINAL SPECULUM?

The FDA 510(k) record lists Innovative Gynecological Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IGS VAGINAL SPECULUM?

The FDA product code for IGS VAGINAL SPECULUM is HIB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: HIB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252208JFord Speculum Sleeve™Ford Medtech, LLCK130046CLEARSPEC SINGLE USE VAGINAL SPECULUMClearspec, LLCK120743SPECULUM, VAGINAL, NONMETALWelch Allyn, Inc.K110766KOLPLUX SYSTEMKolplast CI LtdaK092870NON-STERILE DISPOSABLE VAGINAL SPECULUMKunshan Deyi Plastic Co., Ltd.K091937OFFICE-SPEC DISPOSABLE SIDE-OPENING SPECULUMObp Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑